REPORT On The Implementation of Patient Summary Guidelines in Member States 1

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1 REPORT On The Implementation of Patient Summary Guidelines in Member States 1 Document Information: Document status: Approved by JAseHN spsc Submitted as information to the members of the ehealth Network at their 8 th meeting on vember 015 Yes Document Version: v.0 Document Number: D6.1.1 Document produced by: Author(s): Member State Contributor(s): Stakeholder Contributor(s): Joint Action to support the ehealth Network WP6: Monitoring & Assessment of Implementation Task 6.1: Implementation of ehealth Guidelines Vanja Pajić, HZZO (Croatia) Ana Vrančić-Mikić, HZZO (Croatia) Vesna Kronstein Kufrin, HZZO (Croatia) Martina Orešković, HZZO (Croatia) Tatjana Pavešković, HZZO (Croatia) ATNA (Austria), GEMATIK (Germany), Ministry of Health (Malta), NHS (UK) estandards, Pharmaceutical Group of the European Union (PGEU) 1 Including rway

2 TABLE OF CHANGE HISTORY Version Date Subject Modified by Produced basic draft document after questionnaire analysis Vanja Pajić, Ana Vrančić-Mikić, Vesna Kronstein-Kufrin (HZZO) Updated draft document after additional questionnaire analysis Vanja Pajić, Ana Vrančić-Mikić, Vesna Kronstein-Kufrin (HZZO) Updated document after informal project partners review Vanja Pajić, Ana Vrančić-Mikić, Vesna Kronstein-Kufrin (HZZO) Juergen Wehnert, Beatrice Streit (GEMATIK) Alan Dimech (Government of Malta) Reviewed by WP6 Vanja Pajić, Ana Vrančić-Mikić, Vesna Kronstein-Kufrin (HZZO) Reviewed by WP for quality Marius I. Ungureanu (BBU) check Updated document after review by ehn JA opsc members and WP Vanja Pajić, Ana Vrančić-Mikić, Vesna Kronstein-Kufrin (HZZO) Beatrice Streit (GEMATIK) Jeremy Thorpe (HSCIC) Reviewed by WP and WP1 for quality check Isabella Weber (ATNA) Mara Timofe (BBU), Isabella Weber (ATNA)

3 TABLE OF CONTENTS 1. Foreword.... Executive summary.... Introduction.... tes on methodology Report LEVEL 1: Assessing legal preparedness and interoperability LEVEL : Assessing organisational preparedness and interoperability LEVEL : Assessing semantic preparedness and interoperability LEVEL : Assessing technical preparedness and interoperability Barriers to the implementation of the Patient Summary guidelines Findings Conclusions References Annex: Glossary of terms... 5

4 1. Foreword The objective of this document is to report on the feedback from the Member State (MS) representatives responsible for the implementation of Patient Summary guidelines and to identify the barriers to and facilitators of the implementation of these guidelines in Member States, obtained from the questionnaire on the Patient Summary guidelines implementation created within the framework of the JAseHN project. We believe that the results presented in this report will provide a better understanding of the conditions and barriers faced by Member States in the implementation of the guidelines; it will also form a basis for updating guidelines and establish a clear set of methodological standards for the assessment and monitoring of guideline implementation for future re-use.. Executive summary This report is based on the answers to questions asked in the questionnaire that was distributed to associated and collaborating partners of the JAseHN. 7 Member State representatives (excluding Slovakia) and one non-eu Member State representative (rway) were contacted. The questionnaire was based and focused on the Patient Summary guidelines implementation in Member States. It was assumed that each country representative was in the best position to evaluate the most suitable response for his/her country. The aim of the questionnaire was to collect data on the progress and impact of the Patient Summary guidelines implementation in Member States and to outline some of the barriers for implementation. Conclusions are based exclusively on the questionnaire results and include the feedback received from JAseHN partners.. Introduction The ehealth guidelines implementation was assessed with regard to four interoperability aspects (i.e. levels ) in accordance with the European Interoperability Framework (EIF): 1. Legal (Questions 1-5: Information on legal interoperability). Organisational (Questions 6-15: Information on organisational interoperability). Semantic (Questions 16-5: Information on semantic interoperability). Technical (Questions 6-5: Information on technical interoperability) Member States were asked to answer questions both on the practical aspects of the Patient Summary guidelines implementation (such as barriers to implementation) and on the factual information regarding the state of implementation. Out of 8 countries contacted (Austria, Belgium, Bulgaria, Croatia, Czech Republic, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, rway, Poland, Portugal, Romania, Sweden, Slovenia, Spain and the United Kingdom), 5 countries provided answers to the questionnaire. The countries that have answered the questionnaire are Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, rway, Portugal, Romania, Spain, Sweden and the United The European Interoperability Framework uses the term 'Interoperability layer' when discussing the different aspects of interoperability; see more here:

5 Kingdom. The Netherlands responded too late to be included in this report and Poland and Slovenia did not respond to the call. The main constraint of this report is its reliance on the questionnaire data gathered from Member States. The conclusions were based on responses gathered from national contact points, consisting of their opinion on matters pertaining to the national and cross-border implementation of Patient Summary guidelines, and are only a part of the complete picture. That being said, the answers might have been focused on the national capacity for legal, organisational, semantical and technical interoperability, which may or may not have an impact on the crossborder data sharing capability, and thus represent a Member State s subjective opinion. It should also be noted that some Member States opted for answering most of the questions with or I don t know. The reason for this could be that the questions were unclear or that there was unwillingness to answer on particular aspects of the national ability to share data. It could also be that some of the respondents weren t able to answer the question due to its lack of alignment with the current situation within the respective Member State s internal organisation. From the Member States answers, it seemsthis is particularly true for the technical interoperability section of the questionnaire. Other Member States showed willingness for cross-border healthcare data exchange. However, the fact that the prioritisation of ehealth and other healthcare-related projects is still underway is slowing this process down. Another constraint of this report is the close delivery deadlines and the fact that the questionnaire was conducted during the holiday season.. tes on methodology As a mechanism for obtaining information and opinion, questionnaires offer a number of advantages and disadvantages when compared to other evaluation tools. In general, questionnaires are effective mechanisms for the efficient collection of certain kinds of information. Although there are also some issues that need to be addressed when using questionnaires for data collection, in that the quality of respondent data is probably not as high as with alternative methods of data collection, such as interviews, there are significant benefits to using questionnaires. One key advantage of using questionnaires to collect data is that they permit respondents time to consider their responses carefully without any interference from the interviewer. They are also low-cost, as they can easily be electronically mailed to respondents. Even though the questions need to be both specific and broad, as they need to cover different aspects of a problem and at the same time provide an unambiguous answer, it is possible to provide questionnaires to large numbers of people simultaneously. Questionnaires provide uniformity because each respondent receives an identical set of questions and they are able to address a large number of issues and cover areas of interest in a relatively efficient way, with the possibility of a high response rate. With closed-form questions, responses are standardised, which National organisations that participated in answering the questionnaire are the following: ELGA GmbH (Austria), Federal Ministry of Health (Austria), PFS Public Health (Belgium), BEAT (Bulgaria), Department Information and Communication Policy in Health in the Bulgarian Health Ministry (Bulgaria), IHIS (Czech Republic), Croatian Health Insurance Fund (Croatia), Ministry of Health (Cyprus), Danish ehealth Agency (Denmark), Estonian ehealth Foundation (Estonia), National Institute for Health and Welfare (Finland), French Ministry of Social Affairs and Health (France), Bundesministerium ffn Gesundheit (Germany), rd Regional Health Authority (Greece), AEEK (Hungary), Semmelweis University (Hungary), Department of Health (Ireland), Ministry of Health (Italy), National Health Service (Latvia), National Health Insurance Fund under the Ministry of Health (Lithuania), Vilnius University Hospital Santariskiu Klinikos (Lithuania), Agence esantt (Luxembourg), Government of Malta (Malta), rwegian Directorate of Health (rway), Ministry of Health and Shared Services (Portugal), National Health Insurance House (Romania), Ministry of Health, Social Services and Equality (Spain), Swedish ehealth Agency (Sweden), HSCIC (UK). 5

6 can assist in interpreting answers from large numbers of respondents. In this way, the answers are mutually comparable, although they may lack depth and the root cause of the problem may remain hidden. We have opted for using the questionnaire as the data collection method due to its high distribution rate, standardisation of answers and ease of analysis. 5. Report The following section outlines the results from the Patient Summary guidelines implementation questionnaire. As previously stated, the questionnaire was structured in accordance with the European Interoperability Framework LEVEL 1: Assessing legal preparedness and interoperability Q1. Does your country have a clear legal basis (a national law or other regulatory document) governing the privacy, security and safety issues regarding the use of patient data? Yes 1 0 Figure 1. Question 1 on the legal basis for the use of patient data Q. Does your country have national laws in place that provide a legal basis for the interoperability of the cross-border exchange of personal healthcare data? Yes Figure. Question on the legal basis for the use of patient data in a cross-border setting, i.e. the exchange of patient data across borders 6

7 Q. Has your country established cross-border data controllers? Yes, partially (the the cross border controller role has been partially developed and not fully Yes completely (the the cross border controller role has been established and is running) Figure. Question on the establishment of the data controller role in Member States Q. Does your country implement consent management for the processing and storing of personal and/or patient data and subsequent authorised access? Yes Figure. Question on national consent management regarding the processing and storage of, and authorised access to, personal healthcare data 7

8 Q5. For how long are the patient data log files stored for litigation purposes in your country? Less than/or 10 years 10 More than 10 years 1 1 We don't store patient data for litigation purposes in our country 1 Figure 5. Question 5 on the duration of keeping personal patient data log files Q6. Does the data subject (i.e. a person to whom the personal data relates) know to whom to address questions about access to any of his/her data in the cross-border exchange of information? Yes, both to data controllers and other bodies involved in the crossborder exchange of information Yes, to data controllers but not other bodies involved in the crossborder exchange of information 6 Yes, to other bodies involved in the crossborder exchange of information but not to data controllers 5 5 Figure 6. Question 6 on data subject awareness regarding personal data usage in a cross-border setting 8

9 5.. LEVEL : Assessing organisational preparedness and interoperability Q7. Has your country set up any of the following supervisory bodies for cross-border services monitoring the progress on technical and semantic interoperability and their successful implementation? A support organization that ensures monitoring of interoperability provisions A central service desk for managing incidents An interface between the national and central service desks thing from the above Other Figure 7. Question 7 on the set-up of supervisory bodies charged with implementing cross-border services monitoring the progress on technical and semantic interoperability Q8. If so, are the respective contact details made available to all users by the supervisory body? Yes 7 11 Figure 8. Question 8 on whether respective contact details are made available to all users by the supervisory body Multiple-choice question 9

10 Q9. Has your country put in place assessment tools that allow it to measure the potential quantitative and qualitative benefits and risks (including economic benefits and cost effectiveness) of services? Yes, completely (such tools have been developed and are used for the specified purposes) 5 Yes, partially (such tools have been developed but are not in use, or are not used for the specified purposes) Figure 9. Question 9 on the assessment tools put in place by the Member State authorities to evaluate the potential quantitative and qualitative benefits and risks (including economic benefits and cost effectiveness) of cross-border personal healthcare data services Q10. Does your country have a competent body in place that is responsible for maintaining and/or providing a healthcare provider registry for identification information purposes? Yes Figure 10. Question 10 on the maintenance and/or provision of a healthcare provider registry for identification information purposes 10

11 Q11. Does your country have an ehealth National Contact Point (NCP) for the purpose of ensuring interoperability across national borders with other Member States? Yes, the ehealth NCP role is set up and operates as suggested by the Patient Summary gudelines Yes, the ehealth NCP role is set up but does not operate as suggested by the Patient Summary guidelines Yes, the ehealth NCP role is set up and operates as suggested by the Patient Summary gudelines Yes, the ehealth NCP role is set up but does not operate as suggested by the Patient Summary guidelines 1 1 Figure 11. Question 11 regarding the NCP role and its supported functions Q1. Does your country have a website providing relevant information on the specific rights of data subjects according to the different legislations of all the participating Member States? Yes, we have a website containing this kind of information Yes, we have a website but it doesn't contain the specified information Other 0 Figure 1. Question 1 concerning the existence of a national website containing relevant information on the specific rights of data subjects according to the different legislations of all the participating Member States, as described in the Patient Summary guidelines 11

12 Q1. Does your country use any of the following (answers provided)? Official ID health number for each citizen Unique patient identifier for crossborder patient Electronic registers of health professionals thing from the above Figure 1. Question 1 on the Member State identifiers used for healthcare data management Q1. Has your country implemented a digital signing system for health professionals and healthcare provider organisations? Yes, we have a functional digital signing system, both for health professionals and healthcare provider organizations 9 Yes, we have a functional digital signing system, only for health professionals Yes, we have a functional digital signing system, only for healthcare provider organizations 0 Yes, we have a digital signing system but it is not fully implemented or not used for these purposes Figure 1. Question 1 on the implementation of a digital signing system for health professionals and healthcare provider organisations 5 Multiple-choice question 1

13 Q15. In terms of education, training and raising citizen awareness, which of the following applies to your country (answers provided)? 6 My country undertakes activities towards increasing awareness of the benefits of and need for interoperability and related standards and specifications for electronic crossborder patient data exchange My country set up a permanent facility (a institutional body or a programme) for education, training and awareness raising of patients and healthcare providers regarding healthcare in a cross border setting My country pays particular attention to education, training and dissemination of good practices in electronically recording, storing and processing patient information as well as in gaining the informed consent of the patient and lawfully sharing the pati My country initiates appropriate, easy to understand information and awareness raising measures for all individuals, in particular patients My country provides education and training for promoting a culture of high levels of security and privacy thing from the above Figure 15. Question 15 regarding education, training and raising citizen awareness in cross-border healthcare data exchange 6 Multiple-choice question 1

14 5.. LEVEL : Assessing semantic preparedness and interoperability Q16. Does your country make use of the coding schemes (e.g. Emergency Dataset (EDS), ISO 159, Patient Health Card Data Limited Clinical Data, Hospital Data Project dataset, HL7 Terminology, IHE Recommendations) described in the Patient Summary guidelines? Yes, all 1 Yes, some 0 ne of the above mentioned 1 Figure 16. Question 16 on the usage of standardised coding schemes Q17. Does your country apply commonly agreed upon quality and safety standards in the process of coding the information into patient records, as recommended by the Patient Summary guidelines? Yes, we apply the standards as described in the Patient Summary guidelines 10, we don't use the standards mentioned in the Patient Summary but use our local/national standards 11, we don't use any standards 1 Figure 17. Question 17 on the application of commonly agreed quality and safety standards in the process of coding the information into patient records 1

15 Q18. Has your country established a testing environment that demonstrates compliance with agreed standards for the purposes of cross-border patient information exchange? Yes, we have a testing environment established and in use 5 Yes, we have a testing environment established but it is not currently in use Figure 18. Question 18 on the usage of a testing environment that demonstrates compliance with agreed standards for the purposes of cross-border patient information exchange 15

16 Q19. Which of the following most accurately applies to your country's terminologies in use for cross-border healthcare data exchange (answers provided)? 7 My country complies with internationally used standards for crossborder healthcare data exchange My country complies with standards for crossborder healthcare data exchange used in other Member States My country uses standards for crossborder healthcare data exchange translated into different languages (other than local country languages) My country uses a coding system for crossborder healthcare data exchange that has a maintenance process My country uses transcoding systems/services for crossborder healthcare data exchange My country uses a coding system that is easy to fund in terms of licensing, implementation and maintenance costs (= expert opinion) My country uses a coding system that is easy to implement (i.e. expert opinion) thing from the above Figure 19. Question 19 regarding the Member State terminologies in use for cross-border healthcare data exchange 7 Multiple-choice question 16

17 Q0. Does your country have a translated version of the Master Valuesets Catalogue (MVC) in your country's local language(s)? Yes 11 7 Figure 0. Question 0 on the existence of a translated version of the Master Valuesets Catalogue (MVC) in the national/local language(s) Q1. Does your country apply commonly agreed upon rules for quality and safety when creating catalogue entries with regard to the MVC? Yes 10 7 Figure 1. Question 1 on the application of commonly agreed upon rules for quality and safety when creating catalogue entries with regard to the MVC 17

18 Q. Has your country set up a competent body that is responsible for the accuracy and integrity of the semantic translation, mapping and transcoding process of cross-border healthcare data? Yes, we have a competent body in place that is charged with the responsibility for the accuracy and integrity of the semantic translation, mapping and transcoding process of cross-border healthcare data 7 Yes, we have a competent body in place but it doesn't fulfill the specified roles 1 1 Figure. Question regarding the set-up of a competent body that is responsible for the accuracy and integrity of the semantic translation, mapping and transcoding process of cross-border healthcare data Q. Does your country use testing mechanisms that demonstrate compliance with agreed standards for the purposes of cross-border patient information exchange? Yes, we have the testing mechanisms in place and are using them for the specified purpose Yes, we have the testing mechanisms mentioned but don't use them for the specified purpose Figure. Question on the use of testing mechanisms that demonstrate compliance with agreed standards for the purposes of crossborder patient information exchange 18

19 Q. Is your country's software solution supporting cross-border healthcare data in compliance with the HL7 Clinical Document Architecture (CDA) Version, Level, with the additional constraints of the HL7 Continuity of Care Document (CCD) and IHE Patient Care Coordination (IHE PCC)? Tick the appropriate boxes HL7 Clinical Document Architecture (CDA) Version, level with the additional constraints of the HL7 Continuity of Care Document (CCD) IHE Patient Care Coordination (IHE PCC) My country's software solution supporting crossborder patient data exchange makes use of another data exchange standard not mentioned here My country's software solution supporting crossborder healthcare data exchange doen't currently make use of a data exchange standard thing from the above Figure. Question regarding the use of the software solution supporting cross-border healthcare data in compliance with the HL7 Clinical Document Architecture (CDA) Version, Level with the additional constraints of the HL7 Continuity of Care Document (CCD) and IHE Patient Care Coordination (IHE PCC) 8 Multiple-choice question 19

20 Q5. Is your country's software solution supporting cross-border exchange of personal healthcare data exchange regularly tested for compliance with the adopted normative standards set up by epsos, i.e. IHE and HL7 data exchange standards? Yes, it does for all the specified standards Yes, for some of the specified standards Figure 5. Question 5 regarding the software solution supporting cross-border exchange of personal healthcare data exchange being regularly tested for compliance with the adopted normative standards set up by epsos, i.e. IHE and HL7 data exchange standards 5.. LEVEL : Assessing technical preparedness and interoperability Q6. Is your country able to incorporate (i.e. send and receive) information on crossborder healthcare data exchange from external sources? Yes, completely 0 Yes, partially Figure 6. Question 6 regarding the Member State s ability to incorporate (i.e. send and receive) information on cross-border healthcare data exchange from external sources 0

21 Q7. Does your country have in place a standardised software solution supporting crossborder exchange of personal healthcare data, with specifications of protocols, procedures and exchanged documents? 9 Yes, an OpenNCP Portal solution Yes, an epsosweb solution Yes, a national solution based on epsos functional specifications thing from the above Figure 7. Question 7 on the standardised software solution supporting cross-border exchange of personal healthcare data Q8. Does your country make use of the open-source components developed in epsos and made available to all in the JoinUp EC-supported Open Source Community? Yes 11 9 Figure 8. Question 8 on the use of the open-source components developed in epsos and made available to all in the JoinUp ECsupported Open Source Community 9 Multiple-choice question 1

22 Q9. Which of the following functionalities apply to your software solution supporting cross-border exchange of personal healthcare data exchange (answers provided)? Security management Health professional authentication Patient identification Consent management Document exchange Audit logging Documenting of the semantic transformation between national structure, adopted coding systems and language and the document thing from the above Other Figure 9. Question 9 regarding the software solution supporting cross-border exchange of personal healthcare data 10 Multiple-choice question

23 Q0. Has your country established a software solution supporting cross-border exchange of personal healthcare data in a way that supports the environments for interoperability testing, clinical end validation, data quality improvement and the operation environment for patient data exchange (answers provided)? 11 Yes, with an interoperability testing environmnent Yes, with a clinical end validation environment Yes, with data quality improvement environment Yes, with operation environment thing from the above Figure 0. Question 0 regarding the establishment of a software solution supporting cross-border exchange of personal healthcare data in a way that supports the environments for interoperability testing, clinical end validation, data quality improvement and the operation environment for patient data exchange, as proposed by the Patient Summary guidelines Q1. Does your country use secure communication and perform end-to-end security measures with regard to identifiable personal health data? Yes, for all identifiable personal health dana Yes, for some of the identifiable personal health dana 5 1 Figure 1. Question 1 on the use of secure communication and end-to-end security measures with regard to identifiable personal health data 11 Multiple-choice question

24 Q. Does your country use system logs with regard to handling identifiable personal health data (answers provided)? Yes, for all identifiable personal health data Yes, for some of the identifiable personal health data Figure. Question on the use of system logs with regard to handling identifiable personal health data

25 Q. Which of the following most accurately applies to your country's software solution supporting cross-border exchange of personal healthcare data (answers provided)? 1 All technical staff implementing the project are provided with clear, written instructions on how to use the cross-border system appropriately in Suitable arrangements are made in using the Patient Summary and prescription storage and archiving systems to protect the data from For data exchanges, secure communication protocols and end-to-end-security be adopted Special attention is paid to adopting a reliable and effective electronic identification system that provides the appropriate level of assurance (of The system is capable of correctly recording and tracking the individual operations that make up the overall data processing in an auditable way Unauthorized data access and/or changes is prevented when the back-up data is transferred and/or stored In emergency situations, any access can be logged and is subject to audit thing from the above Figure. Question regarding the software solution supporting cross-border exchange of personal healthcare data 1 Multiple-choice question 5

26 Q. Does your country maintain a full audit trail for personal and sensitive data within your patient data management systems? Yes 17 Figure. Question regarding the software solution supporting cross-border exchange of personal healthcare data Q5. Does your country's software solution supporting cross border exchange of personal healthcare data maintain a log functionality that discerns who has accessed patient information, when was it accessed and what information was requested? Yes, with all the specified functionalities 10 Yes, partially with some of the specified functionalities Figure 5. Question 5 on log functionality that discerns who has accessed patient information, when was it accessed and what information was requested 6

27 Q6. Which of the following most accurately applies to your country's experiences in the use of cross-border healthcare data exchange in terms of barriers to the implementation of the Patient Summary guidelines (answers provided)? 1 Lack of national sponsorship (no one takes the lead or it is unclear who is responsible for leading the Lack of a clear national business case for implementing the Patient Summary guidelines Resistance and criticism from national stakeholders Difficulty in changing current legal model (Unsuitable or incomplete national legislation) Organizational hurdles (various and perhaps ambiguous responsibilities) Unclear or scattered responsibility (e.g. because there are several regional health data systems) Lack of a clear financing procedure (It is unclear who is responsible for financing the implementation of Lack of clinical acceptability of the Patient Summary guidelines Other, more urgent, ehealth priorities Other, more urgent, healthcare priorities Reconcilability of professional terminologies is not possible Lack of data completeness (Ommittance of important patient information in crossborder Low data quality (Patient information in crossborder exchange is difficult to evaluate and accept in Technical hurdles (Scattered IT systems, no unified interfaces between information providers) Burdensome existing IT systems (Legacy information systems in use are difficult to replace) Software licensing problems thing from the above There were no problems faced. Implementation went without noticeable issues. Other Figure 6. Question 6 on cross-border healthcare data exchange and barriers to the implementation of the Patient Summary guidelines 1 Multiple-choice question 7

28 5.5. Barriers to the implementation of the Patient Summary guidelines Q7. In your opinion, are the Patient Summary guidelines in conflict with national professional bodies? Strongly disagree: Strongly agree: 5 0 Figure 7. Question 7 on the possibility that the Patient Summary guidelines are in conflict with other national stakeholders Q8. Do you believe the Patient Summary guidelines are robust and evidence-based? Strongly disagree: Strongly agree: 5 5 Figure 8. Question 8 on the Patient Summary guidelines being robust and evidence-based 8

29 Q9. Do you believe that the Patient Summary guidelines implementation will achieve better patient outcomes? Strongly disagree: Strongly agree: 5 10 Figure 9. Question 9 regarding the opinions on whether the Patient Summary guidelines' implementation will achieve better patient outcomes Q0. In your opinion, are the methods and steps needed for implementing the Patient Summary guidelines clear from the document itself? Strongly disagree: Strongly agree: 5 1 Figure 0. Question 0 regarding the clarity of methods and steps needed for implementing the Patient Summary guidelines 9

30 Q1. Do you have the right infrastructure to implement the Patient Summary guidelines? Strongly disagree: Strongly agree: 5 Figure 1. Question 1 regarding the infrastructure needed for implementing the Patient Summary guidelines Q. Do you find it difficult to prioritise particular elements of the Patient Summary guidelines in order to implement them in an efficient manner? Strongly disagree: Strongly agree: 5 Figure. Question regarding the prioritisation and efficient implementation of the Patient Summary guidelines 0

31 Q. Do you think that the Patient Summary guidelines implementation can be sustained in the long term? Strongly disagree: Strongly agree: 5 8 Figure. Question regarding the sustainability of the Patient Summary guidelines implementation 1

32 6. Findings The questionnaire results indicate that in most EU countries the Patient Summary guidelines implementation is at an early stage. Although some countries already have in place many of the components necessary for supporting the Patient Summary guidelines implementation, in most Member States the implementation of the recommended interoperable public services has not yet been finished. Although most Member States actively participate in cross-border interoperability projects such as epsos, PARENT, EXPAND, esense and others, testing the national infrastructure and preparing the interoperability framework for cross-border data exchange, there remains the problem of the full deployment of all services envisioned by the Patient Summary guidelines. Member State feedback suggests that the prioritisation of other national projects in healthcare is one of the main obstacles to the full deployment of ehealth services recommended by the Patient Summary guidelines. At this point, the cross-border data exchange is perceived as a secondary issue for most Member States. Furthermore, due to healthcare system decentralisation in some Member States, both institutionally and geographically, historically there has not been a consolidated approach to technical and organisational aspects of cross-border interoperability. Other issues include ongoing project activities with deliverables still waiting to be fully implemented in real-world scenarios. Barriers to the implementation of the Patient Summary guidelines were identified by all Member State representatives; these are related to legal issues, implementation mechanisms (organisational and technical), tracking and coordination, possible internalisation problems and stakeholder engagement. Member States responses show some level of indirect investment in cross-border interoperability, mainly in terms of education and raising awareness. The responses to the questions from the questionnaire show that most Member States have an established legal basis for personal data exchange, especially in terms of privacy, safety and security. What seems necessary, but is not yet fully established, is a cross-border data exchange regulation that would take into account the secondary usage of data by other Member States. Questionnaire responses also show that most Member States have established institutional data controllers to provide information to interested parties (e.g. patients). As a final note, the findings from this report were not based on a root-cause analysis and should not be taken as objective recommendations for further action towards the improvement of the Patient Summary guidelines implementation in Member States. However, the questionnaire analysis shows some patterns that should be taken into account for the purpose of the Patient Summary guidelines update and further implementation.

33 7. Conclusions 1 Although Member States expressed interest in implementing the ehealth guidelines that would lead to the creation of the Cross-Border ehealth Information Services (CBeHIS), there is still the need for some additional steps towards achieving the European Union s Single Market goals for healthcare. Most Member States have the majority of preconditions necessary to start crossborder data exchange in terms of semantic standards, technical solutions and infrastructure support with regard to the ehealth guidelines. However, they still do not have the necessary legal and organisational mechanisms to do so. There are still certain legal and organisational burdens to be tackled before the guidelines can be fully implemented. The technical and semantic uptake of the guidelines has been progressing steadily after the epsos project, but there are some nontechnical burdens to be negotiated before their full implementation. The updated guidelines should probably more seriously take into account the legal and organisational aspects of crossborder data exchange and should focus on recommendations on how to set up legal measures and coordinate the organisational goals of those national institutions that will support the crossborder data exchange. Flexible but permanent legal arrangements and organisational changes aimed at interoperability should ensure the long-term sustainability of these efforts. After epsos, Member States reported that no mechanism for regional Patient Summary consolidation has been implemented beyond proof-of-concept essays. There has been neither enough harmonisation of contradictory contents among healthcare providers nor a shared encoding of values. Moreover, the progress of the conciliation of values has been rather slow. As these are prerequisites for a cross-border healthcare data exchange environment, which should guarantee integrity of information and avoid or document redundant registers, the recommendations on how to achieve this on the organisational level should be explained in more detail in the future. However, Member States showed a high degree of awareness regarding the benefits of enabling cross-border data exchange, and they expressed their motivation to provide public information via ehealth NCP (NCPeH) websites. However, the provision of information can only go so far if the organisational support of the Member States governing authorities does not recognise the need for organisational continuity and legal uptake, which are both lacking. The crucially important next step in the ehealth guidelines implementation is to find the best way to involve a wider community of experts and official authorities that would provide information dissemination and continuity. The updated guidelines could include recommendations on how to include other interest groups that already have access to information on cross-border healthcare. They would then participate in organisational and legal changes towards an improved EU-wide cooperation on raising healthcare standards or improving access to cross-border data. Empowering stakeholders after gaining their trust could be a bottom-up approach to organisational and legal changes. As the improved legislation could bolster the patients' ability to receive both healthcare in other Member States and the reimbursement thereof, thus providing a higher level of treatment, such a change could be of interest to stakeholders outside the healthcare system, so the new legislation should take this fact into account as well. The next step in building a more robust environment providing cross-border healthcare data is the adoption of the more complete ehealth guidelines which would advance from the technical and semantic aspects of interoperability towards legal and organisational ones. What is also needed is the strengthening of the ehealth NCP role in Member States, which should provide continuity and sustainability to all future ehealth implementations. 1 Final conclusions and recommendations were based on the questionnaire data analysis, comments from stakeholders and feedback from project partners.

34 8. References Grol R, Bosch M, Hulscher M, Eccles M, Wensing M: Planning and studying improvement in patient care: The use of theoretical perspectives. Milbank Q 007, 85:9 18. Grimshaw J: Improving the scientific basis of health care research dissemination and implementation. Paper presented at the NIH Conference on Building the Sciences of Dissemination and Implementation in the Service of: Public Health; 007 European Interoperability Framework (EIF) for European public services, available at: (0/07/015)

35 9. Annex: Glossary of terms CONCEPT DEFINITION CBeHIS CEF ehealth EIF European public service Guideline Interoperability framework National Infrastructure NCP NCPeH Cross-Border ehealth Information Services in the scope of the current document, namely Patient Summary and eprescription (may include edispensation) EU financial (7.5M ) mechanism (based on call for proposals) that will be launched by vember 015, and may be used by MS to support CBeHIS provision (preparation, deployment and operation) European Interoperability Framework A cross-border public sector service provided by public administrations, either to one another or to European businesses and citizens A suggestion on how to perform a certain task. It is visible to those using or supporting the use of a particular service but there are no sanctions if not followed. An agreed approach to interoperability for organisations that wish to work together towards the joint delivery of public services. Within its scope of applicability, it specifies a set of common elements such as vocabulary, concepts, principles, policies, guidelines, recommendations, standards, specifications and practices. The healthcare IT infrastructure, which manages patient and HP identification and health care records in MS National Contact Point as referenced in Article of the 011//EU Directive National Contact Point for ehealth that may act as an organisation and technical gateway for the provision of ehealth Cross-Border Information Services 5

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